Infant transport support device

ABSTRACT

An infant transport support device is provided, including a first side; a second side; a top side; a bottom side; a first end; and a second end; and at least one protrusion extending from said top side for supporting a neck of an infant during transport. The top side and bottom side extend from the second end at a 16-30 degree angle, for safely transporting an infant by reducing noise, vibration and/or movement.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.63/199,150 filed Dec. 10, 2020, and is incorporated herein by referencein its entirety.

BACKGROUND

Each year approximately 3,853,472 babies are born in the United States.Of those babies, approximately 380,000 are born prematurely (<37 weeksgestation). In addition, each year approximately ˜2700 babies aretransported to a higher level of care via ambulances and helicopters inthe United States and Canada. Transportation of these premature babiesborn prematurely causes additional stresses to the babies, furtherimpacting in their development and ability to thrive. The stresses tothe baby during transport are extraordinary and cause challenges inproviding optimal developmental care. The primary goal is to improveneonatal transport processes and outcomes by minimizing stressors.

SUMMARY

Providing neonatal developmental care is challenging in the NeonatalIntensive Care Unit (NICU), but is particularly challenging duringtransport. The stresses to the baby and the challenges to developmentalcare for babies during transport are extraordinary. Transportation ofbabies is required when babies are born and require increased medicalsupport including admission to the NICU. This occurs with babies born ina hospital, needing transport to an in-house NICU or born in an outlyinghospital requiring ground transport via ambulance or by air on ahelicopter to a higher level NICU. The inventive embodiments describedherein result in improvement in neonatal transport processes andoutcomes by decreasing sound and vibration to the most vulnerablepatients during both ground and air transport as well as reducing stressto infants on neonatal transport both outside and within the hospital,for example, from the delivery room to the NICU.

Providing optimal care for premature babies requires providing safetransportation for these babies. Oftentimes these babies must betransported by ambulance or by helicopter, resulting in additionalsensory impact. The goals of the inventive embodiments described hereininclude minimizing those negative sensory impacts as well as providingoptimal conditions for the transportation of premature babies. Numerouschallenges arise in manipulating premature babies in preparation for orduring transportation, including proper positioning of the baby to avoidinjury or negative sensory impact to the baby. Premature babies aredisproportionately impacted by very minor stressors that would notaffect full term babies. For example, sound and vibration are majorstressors for both ground and air transports, and these stressorsdisproportionately impact premature babies and can cause long termaffects in their development. Light and positioning have also beenidentified as common stressors during neonatal transport.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description briefly stated above will be rendered byreference to specific embodiments thereof that are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments and are not therefore to be considered to be limiting of itsscope, the embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 includes a cross sectional view of an embodiment of the infanttransport support device.

FIG. 2 is a top plan view of an embodiment of the infant transportsupport device.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles andoperation of the invention, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated device, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to thoseskilled in the art to which the invention pertains.

Studies have shown that reducing sound and vibration and movement of aninfant enhances their development and reduces stress to their developingsystems. Transportation often causes excessive vibration to newborninfants. This is particularly detrimental to premature or sick newbornbabies. Statistics show that the overall incidence of IVH is greaterduring transport as compared to inborn (local hospital), whereintransport accounts for approximately 27.4% of IVH cases, and inbornaccounts for 13.42% of IVH cases. Severe IVH is higher in transportcompared to inborn, wherein transport accounts for 44.1% of severe IVHcases, as compared to 32.9% for inborn cases.

Additionally, controlling or inhibiting sound impacts to these newborninfants is particularly difficult, but particularly important. Mostknown hearing protection devices are large and bulky, and ineffectiveagainst low frequency noise.

Consequently, embodiments provided herein address both the reduction orelimination of movement or vibration and/or the reduction or eliminationof sound (in one example by providing ear protection) for babies,particularly during transportation. Combining these solutions as well assupporting correct positioning of the baby during transport is crucialin facilitating safe and healthy transport by reducing risk factors.

In at least one embodiment described herein, there is provided an infanttransport support device including a first side, a second side, a topside, a bottom side, a first end and a second end. The device mayinclude at least one protrusion extending from said top side of thedevice for supporting a neck of an infant during transport. Theprotrusion may extend from the top surface of the top side and maypartially, or fully extend from the first side to the second side of thedevice. The protrusion provides sufficient support to the head and neckof the baby placed on the device, to support the head and neck inneutral position. The protrusion is configured to contact and support aneck of the baby. In some non-limiting embodiments, the protrusion maybe removable from the device and/or adjustable in position and sizerelative to the device to allow for various sizes of babies to be placedthereon. For example, depending on the anatomy of the particular baby tobe supported by the infant transport support device, the protrusion maybe placed closer to a first end of the device or to a second end of thedevice such that the protrusion supports a neck of a baby. Inembodiments wherein a second protrusion is included, the secondprotrusion may support the gluteus or feet of the baby to reducedownward movement (i.e., movement toward the second end 114) of thedevice 100 further maintaining position of the baby during transport onthe device 100. In one example, the protrusion 122 may include aninflatable device attachable to or extending from the top surface of thetop side of the device 100. The inflatability allows for adjustabilityof the size and depth of the protrusion to increase or decrease thedistance between the top of the protrusion 122 and the top surface 118of the top side 110, accounting for babies of different sizes andcharacteristics. Proper support of the head and neck provides effectiveintubation procedures while maintaining neuroprotection positioning. Thedevice embodiments described herein prevent cervical rotation, cervicalflexion and cervical hyperextension, which are the main causes of IVH.The elevation of the device may vary, or the device may be provided inmultiple sizes and elevations. In at least one embodiment, the devicemay include an elevation of between 16-30 degrees. In one example, thetop side and bottom side may extend from the second end at at least 10degrees, in another example, the top side and bottom side may extendfrom the second end at at least 15 degrees. In yet another example thetop side and bottom side may extend from the second end at a 16-30degree angle. During transport, there are space restraints that must beconsidered due to the size and dimensions of the isolettes and transportisolettes. For an in-house incubator, a 30-degree elevation isrecommended. Increasing the elevation of the first side of the devicebetween 15-45 degrees decreases the incidence of intraventricularhemorrhage for babies born between 22-32 weeks gestation (or less than1500 grams birth weight). In one non-limiting embodiment, an angle (θ)created between the top side and bottom side of the device may includebetween a 16-30 degree angle or the other angels discussed herein (atleast 10 degrees, at least 15 degrees, etc.). In one specificnon-limiting embodiment shown in FIG. 1, the angle formed between thetop side 118 and the bottom side 112 at the second end 114 of the devicecomprises a 16-degree angle.

The device may further include a first and/or a second lateral border130, 132 as shown in the top plan view of FIG. 2, extending from the topsurface of the top side or the first or second side 134, 136 forreducing movement of an infant placed on the device, and for aligningthe trunk and head of the infant in a neutral spine with flexionsupport. The first and/or second lateral border 130, 132, may onlyextend partially along the first or second side, respectively, inanother non-limiting embodiment. The first sand/or second lateral border130, 132 may be formed as a contour that protrudes vertically from thetop surface 118 of the device 100. The first and/or second lateralborder 130, 132 may be continuous with the protrusion 120. Inembodiments with the first and/or second lateral borders 130, 132, ababy placed on the device 100 is prevented from falling into extensiondue to gravity. These first and/or second lateral borders 130, 132 mayalso secure the baby when on transport and support and protect the babyduring movement and vibration from the ambulance or helicopter oftenresulting in movement of the baby. The lateral border(s) 130, 132 may bepositioned at the level of the scapula of the infant, in one embodiment.The first and/or second lateral borders 130, 132 may be adjustablerelative to the device and relative to the infant placed thereon. Thestructural elements of the device prevent long term scapular externalrotation and retraction, which can impact a baby by causing rib cageelevation, negatively effecting respiratory effort, spinal extension andanterior pelvic tilt, by placing the baby in a resting posture that thebaby will need to learn to actively overcome in order to learn how tobreathe and eat and interact.

When long tern positioning persists (even when it is medicallyimperative), the effects can be far reaching and have greater, longlasting effects on daily function during these critical hours of earlydevelopment.

At least a second protrusion may be provided in another embodiment,which may extend from the top side of the device, and as with the firstprotrusion, may be removable from the device or adjustable thereon, ormay be permanently fixed relative to the device. The second protrusionprevents downward movement of the infant, preventing the infant fromsliding down on the mattress and further securing its position.Moreover, this second protrusion may be provided to facilitate pelvictilt with trunk and hip flexion to the midline.

A notch 134may be formed in the top surface of the device 100, in anon-limiting example, to provide infant head stabilization. This may beformed by a dip or molding into the device on the top surface 118 of thetop side of the device, in one example. Head stabilization may also beprovided by the lateral borders 130, 132 described above. The amount ofsupport within the device 100 may be adjustable in some non-limitingembodiments, wherein it may be filled or wherein the support may beremoved from the inside of the device 100. In one example, the device100 may include a zipper or button or other closure to provide access tothe internal portion of the device 100. The adjustability may beadvantageous for a baby that requires more prone positioning, whereinadditional internal filler material may be inserted into the internalportion of the device 100 to provide such positioning.

The device may be formed, at least part, of memory foam and/or springsto reduce vibration and provide supportive comfort to an infant placedthereon, in non-limiting embodiments. The effects of vibration oninfants, particularly premature infants can be detrimental.

The device may be provided for single patient use to enhance infectioncontrol, in some non-limiting embodiments. For example, a removable,disposable covering may surround the device for use. The cover may benon-permeable, but breathable for comfort, and for maintaining patienttemperature, and can be removed from the device for cleaning or disposalto allow re-use of the device. The device may allow for unobstructedx-ray procedures to reduce disturbances to the infant which are causedby removing and replacing the infant onto the device between scans.

Embodiments of the device may further include a shade device 140 shownin FIG. 2 adaptable to be removably affixed to the top portion of thedevice 100 for decreasing light stimulation, and reducing noise in oneexample. The shade140 may be removable from or permanently attached tothe device. The shade 140 may be movable relative to the device, in somenon-limiting examples, it may be rotatable and/or slidable relative tothe device to accommodate various sizes of babies and position the shadeto provide the most benefit for the baby. The shade 140 may preventlight disturbance from interfacing with the baby and reduce need forattachments to the baby. It is imperative to protect the eyes ofinfants, particularly premature infants, as the eyes are the last organsto develop. Oftentimes, premature babies are born with underdevelopedeyesight, and thus, protection of the eyes is of utmost importanceduring the final developmental stages of these babies. Babies that are<1500 grams or less than 32 weeks gestation are at risk for retinopathyof prematurity, therefore eye protection is crucial for these preemies.The device may further include, in non-limiting embodiments, noisecancelling features, including a noise cancelling system. Thenoise-cancelling system may be a component of the shade device. Thenoise cancelling system may be a component of a helmet placed over theinfants head, or can be placed inside the transport isolette and the inhouse isolette. The noise cancelling system may alternatively be acomponent of the shade device.

The device may ideally be adjustable to accommodate various sizes ofbabies, including Low Birth Weight babies (LBW) which weigh less than2500 g, very low birthweight babies (VLBW), weighing less than 1500 g,and extremely low birth weight babies (ELBW), weighing less than 1000 g.In some examples, the lower portion of the device may be adjustable toincrease or decrease pelvic support. Adjustable lateral head and trunksupports may be removable from and attachable to the device or builtinto the device for providing additional support to various sizes ofinfants.

The structural characteristics of the device embodiments describedherein reduce the need for straps and attachments to the baby. From asensory perspective, all points of physical contact on a baby sendmessages to the brain. The brain registers and interprets the response.At first the baby may go into fight mode; however, when the sensationpersists (i.e.—strapping, tape) the baby's sensory system goes into aflight mode and often times shuts down. Both of these physiologicalresponses have devastating short and long-term impacts on the baby'ssensory system (ability to interpret stimuli in the environment) as wellas its endocrine (stress response) system.

In some embodiments, the device may include accessory support includingsupport structures to secure respiratory tubing and devices, forexample. The device may include a material to provide security forplastic tubes, and other accessories, to prevent slipping through forairway, (endotracheal tubes, CPAP, nasal cannula) extending therefrom toprevent pulling the baby into position, or on the nose and face. Thetype of material that could be utilized would be of one that wouldmaintain a tube or other accessory in place and prevent slipping. Thesefeatures would decrease the need to continue moving the infant toaccommodate tubes slipping out of the holder, which occurs often withoutthe device embodiments described herein. The intubation tubing isnecessary when indicated, but considerations for direction of pullshould be always be made. Once there is this high arch in the palateusually caused by long-term intubation, a baby is at a disadvantage frombaseline and will need to work harder to maintain suck on a pacifier aswell as demonstrate oral motor coordination for safe and efficientextraction of milk from nipple for adequate weight gain. A baby with ahigh palate will have to work harder to get milk from breast or bottledue to this shift on oral motor anatomy. Feeding implication and effectsreach far beyond days spent in the NICU. For example, the endotrachealtube is left in the mid-line position for a long period of time theinfant's palate will start to surround the tube thus creating a highpalate. The endotracheal tube must be moved from side to side of theinfant's mouth. Furthermore, the tension on the infant's mouth due tothe endotracheal tube pulling needs to eliminated. Securing the tubewith a securement device that does not slip, as described hereinprevents these issues.

It is to be noted that the terms “first,” “second,” and the like as usedherein do not denote any order, quantity, or importance, but rather areused to distinguish one element from another. The terms “a” and “an” donot denote a limitation of quantity, but rather denote the presence ofat least one of the referenced item. Furthermore, to the extent that theterms “including,” “includes,” “having,” “has,” “with,” or variantsthereof are used in either the detailed description and/or the claims,such terms are intended to be inclusive in a manner similar to the term“comprising.” The modifier “about” used in connection with a quantity isinclusive of the stated value and has the meaning dictated by thecontext (e.g., includes the degree of error associated with measurementof the particular quantity). It is to be noted that all ranges disclosedwithin this specification are inclusive and are independentlycombinable.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a,” “an,” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise theseterms do not denote a limitation of quantity, but rather denote thepresence of at least one of the referenced item. Furthermore, to theextent that the terms “including,” “includes,” “having,” “has,” “with,”or variants thereof are used in either the detailed description and/orthe claims, such terms are intended to be inclusive in a manner similarto the term “comprising.” Moreover, unless specifically stated, any useof the terms first, second, etc., does not denote any order, quantity orimportance, but rather the terms first, second, etc., are used todistinguish one element from another.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope are approximations, the numerical values set forth inspecific non-limiting examples are reported as precisely as possible.Any numerical value, however, inherently contains certain errorsnecessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all sub-ranges subsumedtherein. As a non-limiting example, a range of “less than 10” caninclude any and all sub-ranges between (and including) the minimum valueof zero and the maximum value of 10, that is, any and all sub-rangeshaving a minimum value of equal to or greater than zero and a maximumvalue of equal to or less than 10, e.g., 1 to 7.

What is claimed is:
 1. An infant transport support device, comprising: afirst side; a second side; a top side; a bottom side; a first end; and asecond end; and at least one protrusion extending from said top side forsupporting a neck of an infant during transport, and wherein the topside and bottom side extend from the second end at a 16-30 degree angle.2. The infant transport support device of claim 1, further comprising afirst and/or a second lateral border between from the top and bottomsides for reducing movement of an infant placed on the device.
 3. Theinfant transport support device of claim 1, further comprising at leasta second protrusion extending from the top side of the device forlimiting downward movement of the infant.
 4. The infant transportsupport device of claim 2, wherein the first and/or second lateralborders are removable.
 5. The infant transport support device of claim1, wherein the device comprises memory foam to reduce vibration to thebaby during transport.
 6. The infant transport support device of claim1, wherein the device comprises one or more springs disposed between thetop side and the bottom side to reduce vibration to the baby duringtransport.
 7. The infant transport support device of claim 1, furthercomprising a removable shade device for decreasing light stimulation. 8.The infant transport support device of claim 1, further comprising anotch configured for receiving and positioning a head portion of a baby.9. The infant transport support device of claim 1, wherein theprotrusion is contiguous with the top surface of the device.
 10. Theinfant transport support device of claim 2, wherein the protrusion isassociated with the first and/or second lateral border.
 11. The infanttransport support device of claim 2, wherein the first and/or secondlateral border is adjustable relative to the device.
 12. The infanttransport support device of claim 2, wherein the first and/or secondlateral border is removable.
 13. A method for positioning an infantduring transport, comprising: placing an infant on the infant supportdevice of claim 1, such that a neck of the infant is positioned at thefirst protrusion, and a midline of the infant is centered between thefirst and second side of the device, such that the device reducesvibration and/or movement of the infant during transport.
 14. The methodof claim 14, further comprising a notch configured to receive a headportion of the infant, such that the head is positioned at the notchportion to reduce movement of the head during transport.
 15. The methodof claim 13, further comprising a removable shade for placement over thetop surface of the device, such that the shade reduces light and/orsound to the infant.